Volume 7.05 | Feb 13

Volume 7.05, February 13, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Antibodies and Adult Stem Cells Treat Paralysis: The New Scientist reports that two antibodies that enabled the severed spinal nerves of rats to be regenerated will be tested in humans.
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Science

Stem Cell Breakthrough Helps 85% Of Type 2 Diabetes Patients
A study carried out in Argentina by a team of researchers from a Not-For-Profit Organization called ‘Don Roberto Fernandez Viña Foundation’ (San Nicolas- Buenos Aires, Argentina) demonstrated that stem cells implanted into type 2 diabetes patients, in direct form into the pancreas, improve the production of Endogenous Insulin, increase the levels of “C Peptide”, decrease blood glucose levels and glycated hemoglobin levels faster than other treatments.
Article

Infant Transplant Patients Resist Infections that Kill Adult AIDS Patients
This discovery indicates a hidden safety net that might have far-reaching consequences for treating diseases of the immune system such as AIDS.
Article

Gene Therapy Offers New Hope For Heart Patients
Gene therapy research going on in Colorado is showing promising results for new treatments of severe heart disease. The new technique being tested at the Medical Center of Aurora is offering hope to people who can’t be helped by standard treatments like by-pass or angioplasty.
Article

‘I Now Have A Face’ Says Face Transplant Recipient
Isabelle Dinoire, the first person to receive a face transplant, said ‘I now have a face like everyone else’ in her first news conference held today in Amiens, France.
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Testing Stem Cells For Peripheral Artery Disease – Indiana University School Of Medicine Has Begun Unique Clinical Trial
Indiana University School of Medicine scientists have begun a unique clinical trial using stem cell injections as a treatment that could offer hope to tens of thousands of people who face sores, ulcers and even amputations due to severe peripheral artery disease.
Article

Edinburgh Scientists Identify A Key Player In Making Specialised Cells From Embryonic Stem Cells
Scientists from the University of Edinburgh have shown that the protein Mbd3 plays a crucial role in the process by which embryonic stem cells become specialised cells, such as brain or skin cells.
Article

The International Stem Cell Forum Welcomes California Institute for Regenerative Medicine
The International Stem Cell Forum (ISCF) announced at its annual meeting that the California Institute for Regenerative Medicine (CIRM) has been invited to join.
Article

Scientists Force Viruses to Evolve as Better Delivery Vehicles for Gene Therapy
UC Berkeley’s David Schaffer, associate professor of chemical engineering and a member of the Helen Wills Neuroscience Institute, with colleagues Narendra Maheshri, James T. Koerber and Brian Kaspar, decided to speed up the process of viral evolution and direct the change in a way that would allow the virus to slip past the body’s immune defenses, making it a more viable vehicle for gene therapy.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

A Clonogenic Bone Marrow Progenitor Specific for Macrophages and Dendritic Cells
Thus, macrophages and DCs appear to renew from a common progenitor, providing a cellular and molecular basis for the concept of the MPS.
Abstract

Gastrointestinal Stem Cells. III. Emergent Themes of Liver Stem Cell Biology: Niche, Quiescence, Self-renewal, and Plasticity
This essay will address areas of liver stem/progenitor cell studies in which consensus has emerged and in which controversy still prevails over consensus, but it will also highlight important themes that inevitably should be a focus of liver stem/progenitor cell investigations in coming years.
Abstract

Mannan-MUC1–Pulsed Dendritic Cell Immunotherapy: A Phase I Trial in Patients with Adenocarcinoma
Immunization produced T-cell responses in all patients with evidence of tumor stabilization in 2 of the 10 advanced cancer patients treated. These data support further clinical evaluation of this dendritic cell-MFP immunotherapy.
Abstract

Policy

US Senator Jim Talent Takes New Tack on Stem Cells
In a surprise turnabout, Sen. Jim Talent withdrew his support Friday for a controversial ban on human cloning and offered what he said was a compromise proposal that would heal the deep divide over stem cell research.
Article

Business

RheoGene Grants Ichor Medical Systems a Commercial License to Develop a Regulated Gene Therapy for Multiple Sclerosis Using the RheoSwitch® Therapeutic System
RheoGene, Inc., announced today that it has granted a commercial license to Ichor Medical Systems for use of its RheoSwitch® Therapeutic System (RTS) in combination with Ichor Medical Systems’ proprietary TriGrid™ Delivery System electroporation technology to develop a gene therapy product for multiple sclerosis.
Article

Pluristem Files Patent Application For Expanding Hematopoeitic Stem Cells (HSC) and Early Progenitor Cells from Cord Blood Non Selected Mono-Nuclear Cells (MNC)
Pluristem Life Systems, Inc. (OTC BB:PLRS – News), a biotechnology company dedicated to the expansion of stem cells from umbilical cord blood to address a myriad of fatal illnesses, today announced that a patent application has been filed with the US Patent and Trademark Office for a new procedure for expanding Hematopoeitic Stem Cells (HSC) and early progenitor cells from Cord blood from non selected mono-nuclear cells (MNC) of the cord blood.
Article

Leading Stem Cell Company Launches Research Facility in California
Advanced Cell Technology, Inc. (OTCBB:ACTC) has announced today that it has opened a new 15,000 square foot state-of-the-art facility in Alameda, California that encompasses a 10,000 square foot Good Manufacturing Practice (GMP) capable laboratory.
Article

ReNeuron Signs Manufacturing Contract with Angel Biotechnology for Its ReN005 Stem Cell Line for Huntington’s Disease
ReNeuron Group plc (LSE: RENE.L) today announced that it has signed a manufacturing contract with Angel Biotechnology Holdings plc, the UK biopharmaceutical contract manufacturer.
Article

Medistem Laboratories Executes Agreement to License its Intellectual Property to Institute for Cellular Medicine; Agreement to Enable Clinical Research Programs and Delivery of Medistem’s Stem Cell Therapies by ICM
Medistem Laboratories, Inc. (OTCBB:MDSM – News; FWB:S2U), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, has announced that it has executed a technology licensing and royalty agreement with the Institute for Cellular Medicine (ICM), an international laboratory and clinic affiliate.
Article

Medistem International Licensee ICM Establishes Ethical Advisory Board to Guide Advanced Stem Cell Research
Medistem Laboratories, Inc. (OTCBB:MDSM) (FWB:S2U), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, has announced that its international laboratory and clinical licensee, the Institute for Cellular Medicine (ICM) in Costa Rica, has established an Ethical Advisory Board that will oversee all treatment protocols at ICM, to ensure the highest ethical practices in clinical research and therapeutic applications of Medistem’s proprietary adult stem cell treatments.
Article

AnorMED (AOM.TO) Reports Fiscal 2006 Third Quarter Results And Announces MOZOBIL(TM) Phase III Recruitment Reaches 50%
Recruitment into the Phase III trials for MOZOBIL continues to make steady progress. To date, 148 out of 300 non-Hodgkin’s lymphoma (NHL) patients and 162 out of 300 multiple myeloma (MM) patients have entered into the Phase III trials.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

NIH Guide for Grants and Contracts – Week Of February 10, 2006
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Clinical Proteomic Technology Assessment for Cancer (U24) (RFA-CA-07-012)
Application Receipt Date(s): April 21, 2006

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NIH Adjusts Timeline for Electronic Application Submission to Provide Additional Time Before the R01 Transition (NOT-OD-06-035)
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CBER

All new CBER information can be reached from the What’s New page at What’s New Page

CBER Organizational Information – Update
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Varicella Zoster Immune Globulin (VZIG) – Anticipated Short Supply and Alternate Product Availability Under an Investigational New Drug Application Expanded Access Protocol
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Supplement Approval – Immune Globulin Intravenous, Human 5% (OCTAGAM) – OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
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Substantially Equivalent 510(k) Device – Pall Acrodose PL System – Medsep Corp
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Substantially Equivalent 510(k) Device – ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) – GTI, INC
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Substantially Equivalent 510(k) Device – HLA Visual Software version 1.0 – One Lambda, Inc
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Substantially Equivalent 510(k) Device – HLATools Software, Version 1.0 – One Lambda, Inc
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Violative Advertising and Promotional Labeling Letter: Rho(D) Immune Globulin Intravenous (Human) Rhophylac – ZLB Behring LLC
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Approved Biological NDA and ANDA Applications – Update
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Cleared Biological 510(k) Device Applications – Update
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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Licensed Products and Establishments List – Update
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FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
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Order to Cease Manufacturing and to Retain HCT/Ps – Biomedical Tissue Services, Ltd
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Regulatory

Food and Drug Administration (United States of America)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
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Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing; Public Workshop; Request for Comments
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Phacilitate Cell & Gene Therapy Forum 2006 and Phacilitate Vaccine Forum 2006 – Slide Presentations
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ISCT

ISCT2006. May 4-7. Berlin.
Click here for the Call for Abstracts and preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Current Volume: Volume 7, Number 6 / December 2005

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
http://journalsonline.tandf.co.uk/link.asp?id=107693